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Study of L19IL2 and L19TNF for Patients with Skin Cancer Suitable for Direct Tumor Injection

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of two treatments, Darleukin and Fibromun, on various types of skin cancer. The skin cancers being studied include basal cell carcinoma, cutaneous squamous cell carcinoma, Merkel cell carcinoma, keratoacanthoma, malignant adnexal tumors of the skin, cutaneous T-cell lymphoma, and Kaposi's sarcoma. The treatments, known by their code names L19IL2 and L19TNF, are administered directly into the tumor as a solution for injection or infusion.

The purpose of the study is to evaluate how effective these treatments are in improving the condition of patients with these skin cancers. The study will involve administering the treatments over a period of up to four weeks. Patients will receive the treatment directly into their tumors, and the response of the tumors to the treatment will be monitored. The study aims to see if the tumors shrink or disappear and to assess the overall response rate of the treatment.

Throughout the study, the safety of the treatments will also be closely monitored. The study will help determine if these treatments can be a beneficial option for patients with skin cancers that are suitable for this type of direct tumor treatment. The results will provide valuable information on the potential of Darleukin and Fibromun in treating these specific types of skin cancer.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed by a local interdisciplinary tumor board. This board evaluates if the treatment may benefit the patient based on their specific skin tumor type and available treatment options.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to confirm the presence of at least one skin tumor suitable for intratumoral injection. All tumors must be confirmed through a biopsy before treatment begins.

  3. Step 3

    Treatment administration

    The treatment involves the use of two medications: Darleukin and Fibromun, which are solutions for injection or infusion. These are administered directly into the tumor (intratumoral use).

    The specific dosage and frequency of administration are determined by the study protocol and the medical team overseeing the trial.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to assess the response to treatment. This includes measuring the size of the tumor and evaluating any changes according to specific criteria.

    Patients may undergo serial biopsies of the injected lesions and, if applicable, non-injected lesions to monitor the treatment's effect.

  5. Step 5

    Evaluation of treatment response

    The main objective is to evaluate the efficacy of the treatment by measuring the best overall response rate, which includes complete and partial responses.

    Secondary evaluations include disease control rate, local progression-free survival, and progression-free survival, among others.

  6. Step 6

    Completion of the study

    The study is estimated to conclude by June 30, 2026. Upon completion, a final assessment is conducted to determine the overall outcomes and any long-term effects of the treatment.

Who can join the trial?

16 criteria

  • The patient must have a positive evaluation from a local interdisciplinary tumor board, which means a group of doctors agrees that the study treatment might help the patient.
  • The patient must have at least one skin tumor that can be injected directly with the study treatment.
  • All tumors must be confirmed by a test called a biopsy before starting treatment.
  • The patient must have skin tumors that fit specific types, such as difficult-to-treat basal cell carcinoma, advanced squamous cell carcinoma, keratoacanthoma, Merkel cell carcinoma, cutaneous T-cell lymphoma, Kaposi's sarcoma, or advanced malignant adnexal tumors of the skin.
  • The patient must have a tumor that can be measured by a scan or physical exam, with at least one tumor being 10 mm or larger in size.
  • The patient must agree to have multiple biopsies, which are small samples taken from the tumor, during the study.
  • The patient must be 18 years or older.
  • The patient must have a good general health status, which is measured by a scale called ECOG Performance Status, and should be 1 or less.
  • The patient must have a hemoglobin level greater than 10.0 g/dL, which is a measure of red blood cells.
  • The patient must have a platelet count greater than 100 x 109/L, which is important for blood clotting.
  • The patient must have liver enzymes (ALT, AST, GGT, and Lipase) at levels not more than 1.5 times the normal upper limit.
  • The patient must have a serum creatinine level less than 1.5 times the normal upper limit and a kidney function test (GFR) greater than 60 mL/min.
  • Any side effects from previous treatments must have improved to a mild level, except for hair loss.
  • Women who can have children must have a negative pregnancy test and use effective birth control during the study and for three months after the last treatment.
  • Male patients with partners who can have children must agree to use two forms of birth control during the study and for three months after the last treatment.
  • The patient must be willing and able to follow the study schedule, including visits, treatments, and tests.

Who cannot join the trial?

5 criteria

  • Patients who have a type of skin cancer that cannot be treated with an injection directly into the tumor.
  • Patients who are not in a situation where the treatment is intended to cure, prepare for surgery, or relieve symptoms.
  • Patients who are not diagnosed with one of the following skin cancers: Basal cell carcinoma, Cutaneous squamous cell carcinoma, Merkel cell carcinoma, Keratoacanthoma, Malignant adnexal tumors of the skin, Tumors from cutaneous T-cell lymphoma, or Kaposi's sarcoma.
  • Patients who are not within the specified age range for the study.
  • Patients who belong to a vulnerable population, which means they might need special protection or care.
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Investigated drugs

  • L19IL2

    is a medication being studied for its potential to treat skin cancers. It is designed to target and stimulate the immune system to attack cancer cells directly at the site of the tumor. This approach aims to enhance the body's natural defenses to fight the cancer more effectively.

  • L19TNF

    is another medication involved in the study, which works alongside L19IL2. It is intended to target cancer cells and help destroy them by promoting inflammation at the tumor site. This can potentially lead to the reduction or elimination of the tumor.

What is already known about the treatment

  • L19IL2

    This medication is administered through intratumoral injection, directly into skin tumors. It is currently in Phase II clinical trials, exploring its effectiveness in treating various skin cancers, including basal cell carcinoma and Merkel cell carcinoma. The main therapeutic indication is for skin cancers that can be treated with direct injection into the tumor. L19IL2 works by targeting specific proteins on cancer cells, enhancing the immune system's ability to attack the tumor. It is classified as an immunotherapy agent.

  • L19TNF

    This medication is also administered via intratumoral injection, targeting skin tumors directly. It is in Phase II clinical trials, being studied for its potential to treat skin cancers such as cutaneous squamous cell carcinoma and Kaposi's sarcoma. The primary therapeutic use is for skin cancers suitable for direct tumor injection. L19TNF functions by binding to tumor necrosis factor receptors on cancer cells, promoting an immune response to destroy the tumor. It is categorized as an immunotherapy drug.

Investigated diseases

  • Basal Cell Carcinoma (BCC)

    A common form of skin cancer that arises from the basal cells in the epidermis. It typically appears as a small, shiny bump or nodule on the skin, often in sun-exposed areas like the face and neck. BCC grows slowly and rarely spreads to other parts of the body, but it can cause local damage if not treated. Over time, it may develop into a larger lesion with a pearly or waxy appearance and visible blood vessels.

  • Cutaneous Squamous Cell Carcinoma (cSCC)

    A type of skin cancer that originates from the squamous cells in the outer layer of the skin. It often presents as a rough, scaly patch or a wart-like growth that may crust or bleed. cSCC can develop on any part of the body but is most common in areas frequently exposed to sunlight. If left untreated, it can grow deeper into the skin and potentially spread to other areas.

  • Merkel Cell Carcinoma (MCC)

    A rare and aggressive form of skin cancer that begins in the Merkel cells, which are found at the base of the epidermis. It usually appears as a painless, firm, red or violet nodule on sun-exposed skin, such as the face, neck, or arms. MCC tends to grow quickly and can spread to other parts of the body, including lymph nodes and internal organs.

  • Keratoacanthoma (KA)

    A skin condition that resembles squamous cell carcinoma and typically appears as a dome-shaped nodule with a central crater. It often develops rapidly over a few weeks and is commonly found on sun-exposed areas of the skin. KA may spontaneously regress over time, but due to its similarity to more serious skin cancers, it is often treated as a precaution.

  • Malignant Adnexal Tumors of the Skin (MATS)

    A group of rare skin cancers that originate from the adnexal structures, such as sweat glands and hair follicles. These tumors can vary in appearance and behavior, ranging from slow-growing to more aggressive forms. They often present as nodules or masses on the skin and can occur anywhere on the body.

  • Tumors from Cutaneous T-cell Lymphoma (CTCL)

    A type of lymphoma that primarily affects the skin, originating from T-cells, a type of white blood cell. CTCL often presents as patches, plaques, or tumors on the skin, which may be itchy or painful. The disease can progress slowly, with skin lesions changing in size and appearance over time.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-518531-10-00Estimated enrolment26 patientsSponsorPhilogen S.p.A.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).